CALGARY, Nov. 22 /PRNewswire-FirstCall/ - SemBioSys Genetics Inc. , a biotechnology company developing a broad pipeline of protein-based pharmaceuticals and non-pharmaceutical products, today announced the completion of a Technology Transfer and Manufacturing Agreement with Cangene Corporation, a biopharmaceutical company and contract manufacturing organization, for the processing and purification of SemBioSys’ plant-produced insulin. The contract is part of the Company’s preparations for its Investigational New Drug Application (IND) and the initiation of clinical trials. Cangene will manufacture insulin for SemBioSys’ preclinical and early stage clinical development.
“Obtaining the services of a credible and reliable manufacturing organization like Cangene is a critical component of our clinical plan for insulin,” said Andrew Baum, President and CEO of SemBioSys Genetics Inc. “The execution of this contract is the second significant development milestone for our insulin program, following on our announcement this past July of successfully achieving commercially viable levels of insulin accumulation in safflower. We continue to advance our insulin development plan. In the near term, we expect to announce the regulatory strategy we will pursue in the U.S. for our insulin product and to receive in vivo and in vitro bioequivalence results comparing insulin produced from safflower to commercially available insulin products.”
With the signing of the contract, SemBioSys intends to immediately begin work with Cangene to implement technology transfer of the manufacturing process, which enables cGMP production of insulin from transgenic safflower. By solidifying the manufacturing capacity for insulin, SemBioSys remains on track to complete its preclinical work and file its IND in the fourth quarter of 2007. Cangene will be responsible for purification of clinical grade material isolated from safflower seed produced by SemBioSys’ proprietary production technology. The contract with Cangene allows SemBioSys to avoid the costs associated with building and maintaining a stand-alone manufacturing facility during the early stages of clinical development.
Demand for insulin for the treatment of diabetes reached an estimated 5,500 kilograms in 2005 and is projected to increase to 16,000 kilograms by 2012. SemBioSys believes its safflower-produced insulin can reduce capital costs compared to existing insulin manufacturing by 70% and product costs by 40%. In addition, because of the ease in scaling-up crop acreage, plant-produced insulin offers significant improvements in the flexibility and speed of scale-up.
About SemBioSys Genetics Inc. (www.sembiosys.com)
Calgary, Alberta-based SemBioSys Genetics Inc. is a biotechnology company focused on the development, commercialization and production of biopharmaceuticals and non-pharmaceutical products based on its plant genetic engineering skills and proprietary oilbody-oleosin technology platform - the Stratosome(TM) Biologics System. Its two lead pharmaceutical product candidates are insulin and a developmental cardiovascular drug called Apo AI. It also has a series of non-pharmaceutical products addressing animal and aquaculture health, nutritional oils and human topical markets. SemBioSys currently has funded partnership agreements with Martek Biosciences Corporation, Lonza Inc. and Arcadia Biosciences, Inc.
About Cangene Corporation
Cangene is one of Canada’s largest biopharmaceutical companies. It was founded in 1984 and is headquartered in Winnipeg, Manitoba. Cangene uses patented manufacturing processes to produce plasma-derived and recombinant therapeutic proteins. Cangene also provides contract research and manufacturing services using its drug-manufacturing expertise and the resources of Chesapeake Biological Laboratories, Inc. (a wholly owned subsidiary). The Company has manufacturing facilities in Winnipeg, Manitoba and Baltimore, Maryland. Cangene’s website, www.cangene.com, includes product and investor information, including past news releases. Chesapeake’s website is www.cblinc.com. Cangene is listed on the Toronto Stock Exchange under the symbol CNJ.
This press release contains forward-looking statements, including, without limitation, statements containing the words “believe”, “may”, “plan”, “will”, “estimate”, “continue”, “anticipate”, “intend”, “expect” and other similar expressions which constitute “forward-looking information” within the meaning of applicable Canadian securities laws, which reflect the Company’s current expectation and assumptions, and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those anticipated. These forward-looking statements involve risks and uncertainties including, but not limited to, changing market conditions, the successful and timely completion of clinical studies, the establishment of corporate alliances, the impact of competitive products and pricing, new product development, uncertainties related to the regulatory approval process and other risks detailed from time-to-time in the Company’s ongoing filings with the Canadian securities regulatory authorities which filings can be found at www.sedar.com. Given these risks and uncertainties, readers are cautioned not to place undue reliance on such forward-looking statements. The Company undertakes no obligation to publicly update or revise any forward-looking statements either as a result of new information, future events or otherwise.
SemBioSys Genetics Inc.
CONTACT: SemBioSys Genetics Inc., Mr. Andrew Baum, President and ChiefExecutive Officer, Phone: (403) 717-8767, Fax: (403) 250-3886, E-mail:bauma@sembiosys.com, Internet: www.sembiosys.com; Investor Relations, RossMarshall, The Equicom Group Inc., Phone: (416) 815-0700 (Ext. 238), Fax:(416) 815-0080, E-mail: rmarshall@equicomgroup.com
